Phase 3
Completed N=838
Intravenous Thyroxine for Heart-Eligible Organ Donors
Brain Death · Heart Failure
Source: ClinicalTrials.gov NCT04415658 ↗
Enrolled (actual)
838
Serious AEs
0.6%
Results posted
Jan 2024
Primary outcomePrimary: Heart Transplanted — 230; 223 Participants — p=0.57
◆ Published Evidence
Established
44citations · ~15 / year
Intravenous Levothyroxine for Unstable Brain-Dead Heart Donors.
Summary
This randomized controlled trial will evaluate whether intravenous thyroxine infusion given to brain-dead organ donors who are eligible to donate hearts for 12 hours will result in more hearts transplanted than saline placebo
Linked Publications (2)
-
Intravenous Levothyroxine for Unstable Brain-Dead Heart Donors.
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A multicenter randomized placebo-controlled trial of intravenous thyroxine for heart-eligible brain-dead organ donors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Heart Transplanted |
230; 223 | 0.57 |
| PRIMARY Graft Function |
224; 213 | <0.001 sig |
| SECONDARY Time Till Off Vasopressors |
22; 25 | — |
| SECONDARY Weaned Off Vasopressors |
143; 152 | — |
| SECONDARY Time to Order Echo |
12; 13 | — |
| SECONDARY Ejection Fraction |
59; 58 | — |
| SECONDARY Lungs Transplanted |
163; 149 | — |
Eligibility Criteria
Inclusion Criteria
- Declared dead by neurologic criteria (brain dead)
- Authorization for organ donation and research
- On one or more vasopressors and/or inotropes
Exclusion Criteria
- Brain death declared more than 24 hours prior
- Only vasopressor is vasopressin
- Weight < 45 kg (100 lbs)
- Known coronary artery disease or history of myocardial infarction
- Known valvular heart disease
- Prior sternotomy or cardiac surgery
- Donor at VA hospital
- Received intravenous or oral thyroxine within past month
- Known HIV+ status
- Other reason donor is unable to receive study drug (determined by on-site personnel)
Data sourced from ClinicalTrials.gov (NCT04415658) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.